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NCT Number: NCT07604012

Holistic Lifestyle mHealth Intervention for Risk Reduction of Type 2 Diabetes Mellitus in Young Adults

The goal of this clinical trial (randomized controlled trial) is to examine the effectiveness of a holistic lifestyle mHealth intervention in reducing the risk of type 2 diabetes mellitus.

The study focuses on young adults aged 20-35 years, recruited from public and private universities in Rawalpindi and Islamabad, who meet the defined inclusion criteria.

The main questions it aims to answer are:

Does a holistic lifestyle mHealth intervention significantly reduce the risk of type 2 diabetes ? Does the intervention improve overall health-related quality of life and lifestyle behaviors, including diet, physical activity, and stress management?

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Key information

Conditions

Type 2 Diabetes Risk Reduction in Young Adults Behavior Behavior, Animal Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Feeding Behavior Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

Researchers will compare participants receiving the holistic lifestyle mHealth intervention (based on "Eat Well, Move More, Stress Less") with a control group receiving standard care or basic health guidance to see if the intervention leads to greater reduction in diabetes risk and improved health outcomes.

Participants will:

Use a culturally tailored mHealth application designed for the Pakistani context Follow lifestyle recommendations focused on diet, physical activity, and stress management Engage with intervention content based on the three core pillars: Eat Well, Move More, Stress Less Participate in periodic assessments, including health measurements and questionnaires Provide feedback on their experience and adherence to the intervention

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Young adults aged between 20-35 years, as defined by the WHO.
  • At risk of diabetes based on self-reported family history or lifestyle habits.
  • Participants who are willing to engage in the mHealth intervention program.
  • Own a smartphone and are familiar with using mobile apps.
  • Complete the informed consent process, agreeing to follow the study protocol, including survey completion and health assessment.

Exclusion criteria

  • Individuals diagnosed with chronic mental or physical illnesses
  • Individuals with hearing or vision loss so severe that they could not access the mobile health intervention.
  • Pregnant women or women who plan on becoming pregnant during the study.
  • Individuals who are already taking part in an equivalent diabetes or health programme.
  • Individuals who are not willing to provide consent.

Treatment and study plan

Holistic mHealth Intervention

Behavioral

The main components of the holistic mHealth intervention include the following: nutritional education, promotion of physical activity, sleep education, and behavioral health support. The integration of these components in mHealth promotes a holistic lifestyle through enhancing overall health-related quality of life.

Other names: mHealth App, mhealth Intervention, Holistic Intervention

Primary outcomes

  1. Improved quality of Life

    Time frame: 6-8 weeks

    Measured using a validated tool, the Short Form Health Survey (SF-36), assessed at baseline and post-intervention. The primary endpoint is the difference in mean risk scores between the intervention and control groups.

    score ≤ 44 indicates weak, 45-63 indicate medium, ≥ 64 indicate good.

Secondary outcomes

  1. Secondary outcome measures include changes in blood glucose level

    Time frame: 8 weeks

    Diabetes risk assessment is assessed through RAPID (Risk Assessment of Pakistani Individual for Diabetes) .

    Changes in blood glucose levels assessd through HbA1c measured in mg/dL at baseline and post-intervention.

  2. Food literacy

    Time frame: 8 weeks

    Food literacy measured by using Self-Perceived Food Literacy Scale Short Form Scoing : <30.6 indicates inadequate-limited food literacy; >31 indicates adequate-excellent food literacy.

  3. Eating Behavior

    Time frame: 8 weeks

    Eating Behavior measured by using Self-Regulation of Eating Behavior Questionnaire for Adults. Scoring: <2.8 indicate Low level, 2.8 to 3.6 indicate Medium>3.6High

  4. Physical Health

    Time frame: 8 weeks

    weight will be combined to report BMI in kg/m^2.

  5. sleep quality

    Time frame: 8 weeks

    Sleep Quality measured by Pittsburgh Sleep Quality Index (PSQI) Scoring

    :0 - No sleep difficulties; 5 or higher - Poor sleep quality

  6. Psychological Distress

    Time frame: 8 weeks

    Psychological Distress will be measured by using Depression, Anxiety and Stress Scale (DASS-21)

    Scoring:

    Depression : 0-9 normal ,14-20 moderate , 28+ severe Anxiety : 8-9 mild , 10-14 moderate Stress: 15-18 mild, 19-25 moderate

Study contacts

Contact information is provided by the study sponsor or research team.

Anmol Ayaz, Phd Scholar

CONTACT

[email protected]

923335791127

Sajida Naz Dr

CONTACT

[email protected]

+92 323 5493535

Sponsors and collaborators

Lead sponsor

Fatima Jinnah Women University

Other

Registry information

Official study title

Effectiveness of Holistic Lifestyle mHealth Intervention for Risk Reduction of Type 2 Diabetes Mellitus in Young Adults: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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